USFDA - Current Affairs Questions and Answers

1)   Which drug injection did USFDA approve on 28th March 2017, the first such for eczema?

a. Dupident
b. Dupitent
c. Dupixent
d. Dupizent
Answer  Explanation 

ANSWER: Dupixent

Explanation:
The U.S. Food and Drug Administration (FDA) on 28 March 2017 approved Dupixent injection to treat adults with moderate-to-severe eczema (atopic dermatitis).

Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.

The injection will have an initial list price of USD 37000 per year, according to Sanofi SA and Regeneron Pharmaceuticals, which developed the drug.

Dupixent is administered as an injection under the skin. The injection’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], that causes swelling.

By binding to the protein, the drug is able to stop the inflammatory response that plays a role in the development of atopic dermatitis.

The safety and efficacy of the injection were established in three placebo-controlled clinical trials with a total of 2119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication.

Atopic Dermatitis

  • Atopic dermatitis is a chronic inflammatory skin disease.
  • It is the most common of the many types of eczema. Its cause is a combination of genetic, immune and environmental factors.
  • In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy.


2)   USFDA has accepted which medical appliance as an important device to save people from heart disease?

a. Heart stent
b. Dissolving heart stent
c. Steel heart stent
d. None of the above
Answer  Explanation 

ANSWER: Dissolving heart stent

Explanation:
USFDA has officially accepted the Dissolving heart stent in the list of valuable medical devices that can be used to save lives from heart disease.

  • BVS or Bioresorbable Vascular Scaffolds also known as dissolving stents are better than other legally available stents for the same use.
  • Close to 99 percent of Indian interventional cardiologists who trained in angiography and angioplasty have value examination from USFDA as an important source of assessment.
  • No medical device can be used in America without USFDA approval